TY - JOUR
T1 - The FAITH and HEALTH Trials
T2 - Are We Studying Different Hip Fracture Patient Populations?
AU - Blankstein, Michael
AU - Schemitsch, Emil H.
AU - FAITH and HEALTH Investigators
AU - Bzovsky, Sofia
AU - Axelrod, Daniel
AU - Poolman, Rudolf W.
AU - Frihagen, Frede
AU - Bhandari, Mohit
AU - Swiontkowski, Marc
AU - Sprague, Sheila
AU - Schottel, Patrick C.
N1 - ACKNOWLEDGMENTS
The authors thank the HEALTH and FAITH Investigators (https://links-lww-com.eur.idm.oclc.org/JOT/B247). EMC Researchers included.
PY - 2020/11
Y1 - 2020/11
N2 - BACKGROUND: Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ≥50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients. METHODS: Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class. RESULTS: The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures. Their mean age was significantly lower than that of HEALTH patients (66 vs. 79 years; P < 0.001). HEALTH trial patients were significantly more likely to be female, have ASA classification Class III/IV/V, and carry a diagnosis of osteoporosis, as compared with the subgroup of FAITH patients with displaced femoral neck fractures (P < 0.001). CONCLUSION: This study demonstrates significant differences between patients enrolled in the 2 trials. Although both studies focused on femoral neck fractures with similar enrollment criteria, patient populations differed. This sheds light on a noteworthy limitation of discordant patient enrollment into randomized trials, despite similar eligibility criteria. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
AB - BACKGROUND: Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ≥50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients. METHODS: Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class. RESULTS: The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures. Their mean age was significantly lower than that of HEALTH patients (66 vs. 79 years; P < 0.001). HEALTH trial patients were significantly more likely to be female, have ASA classification Class III/IV/V, and carry a diagnosis of osteoporosis, as compared with the subgroup of FAITH patients with displaced femoral neck fractures (P < 0.001). CONCLUSION: This study demonstrates significant differences between patients enrolled in the 2 trials. Although both studies focused on femoral neck fractures with similar enrollment criteria, patient populations differed. This sheds light on a noteworthy limitation of discordant patient enrollment into randomized trials, despite similar eligibility criteria. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
UR - http://www.scopus.com/inward/record.url?scp=85092685821&partnerID=8YFLogxK
U2 - 10.1097/BOT.0000000000001930
DO - 10.1097/BOT.0000000000001930
M3 - Article
C2 - 33027159
AN - SCOPUS:85092685821
SN - 0890-5339
VL - 34
SP - S1-S8
JO - Journal of Orthopaedic Trauma
JF - Journal of Orthopaedic Trauma
ER -